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Why can't the FDA disclose what applications they have from potential EpiPen rivals?

GOP Legislators Seem More Interested in Challenging the FDA

EpiPen Maker CEO Says Company Felt $600+ List Price Was 'Fair'

It's Time For the $64,000 Question

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"They're just begging us to look deeper"

"I don't think we saw anyone on either side of the aisle buying what she was selling," Mr. Chaffetz told reporters after the hearing ended. He added that he expected to get "in a tussle" with Mylan for more information but that they'd get it. "They're just begging us to look deeper."

Louise Radnofsky

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"That's all a shell game"

Outside, on camera, Elijah Cummings is returning to his opening thoughts and imagery that Mylan executives will return to their champagne, and, he now adds, on private jets. Consumer assistance programs aren't going to cut it, he added. "That's all a shell game," he said.

He says he's never had an issue that consumers have responded to like this, that he's confident the outrage is bipartisan and that the question remains "how do we get to a solution."

"First thing we've got to do is get information," he said. "We don't even know completely what we're dealing with."

On timing, Mr. Cummings said he expected any congressional action would have to come next session, at the earliest. "Just for us to get to this hearing was a major event," he said.

Legislators Aren't Buying Mylan's Narrative

He referenced the Mylan slogan--seeing is believing--and requested that Ms. Bresch produce contracts with manufacturers, suppliers, distributors, PBMs and other partners.

"I can't speak to all of those contracts," she said, citing confidentiality agreements. She said she would rely on lawyers to make sure the company is compliant with partners.

Mr. Cummings also said he didn't buy the company's story that they were out to make EpiPens widely accessible to American families.

Earlier, Mr. Chaffetz expressed similar doubts, saying that they weren't holding the hearing because people thought they were getting a good deal. He said people were complaining that they couldn't afford the medications they needed.

"It just doesn't smell right," he later said.

Daniela Hernandez

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"I don't think you have been frank with us"

Glenn Grothman of Wisconsin, a Republican, goes last and it's not fully in line with his colleagues, and it's really more of a question. "Is it good for the moral fabric of society" for chief executives to make as much as they do, so much more than their scientists, other employees, or much "more than anyone would know what to do with."

But Mr. Chaffetz isn't finishing on that note. Instead, he has been grilling for details that seems squarely aimed at a return performance down the line, questions about whether EpiPen is an innovator drug or a non-innovator drug, a classification that matters in programs administered by the Centers for Medicare and Medicaid.

Mr. Cummings wants to chastise Ms. Bresch with his final thoughts. He recalled Martin Shkreli asserting his fifth amendment rights rather than answer questions, and tells Ms. Bresch, she might as well have done the same. "I don't think you have been frank with us... and I don't say those words lightly."

He's also unimpressed with patient assistance programs, for the record, and the generic answer. Why didn't she just bring down the price, he asked. "We believe the generic was much more meaningful to ensure we were reaching those patients across all access points," Ms. Bresch says.

Louise Radnofsky

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Martin Shkreli Has Something to Tweet

Meanwhile, the bad boy of surging drug prices, Martin Shkreli, had this comment:

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Some Last Words on Corporate Greed

Some of the last words have fallen to Michelle Lujan Grisham of New Mexico, a Democrat. The room is all but emptied of lawmakers, except for pharmacist Mr. Carter, who's hung around after his exchange, and the chairman and ranking member, Messrs Chaffetz and Cummings.

Things might have gone differently if if the hearing had started or finished earlier, but Rep. Lujan Grisham still seemed to be aiming to finish strong with what she herself describes as a "rant."

"I don't need any answers because I won't get any that are fair, from you or your company," she said. "Maybe because of your greed" Congress will act, she said.

Louise Radnofsky

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Blame, blame, blame

The blame-shifting at the hearing continues. Legislators blame high prices on a lack of competition fueled by the FDA’s inefficiencies. The FDA says there aren’t enough applications for products. When questioned about why the price has gone up so much for EpiPens, Mylan’s CEO blames the U.S. payment system. As Jonathan mentioned earlier, few--if any--solutions to the issue of rising drug prices, which are bloating healthcare costs more generally, have been presented and the hearing is nearing its conclusion.

Daniela Hernandez

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Highlights

Why can't the FDA disclose what applications they have from potential EpiPen rivals?

Doug Throckmorton, deputy director of the center for drug evaluation and research with the U.S. Food and Drug Administration Andrew Harrer/Bloomberg News

Theresa Eisenman of the FDA has a longer version of Mr. Throckmorton's answer from earlier today that he's legally barred from telling the committee what applications they have from potential EpiPen rivals. Here it is in full.

"The FDA is generally prohibited from disclosing confidential commercial information by FDA regulations and applicable statutes. Information about pending drug applications that has not been disclosed by the sponsor is confidential commercial information. Because the number of pending applications for a specific drug product together with publicly available information could disclose the identity of the applicant or applicants, FDA’s practice is not to disclose the number of pending applications. Although FDA cannot disclose this information, a sponsor is able to disclose information about its pending applications."

Louise Radnofsky

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Use of Private Jets Questioned

New Jersey Democrat Bonnie Watson Coleman zoomed in on a question that's tripped up witnesses before: how did Ms. Bresch and her colleagues get to the hearing today? Ms. Watson Coleman got the answer that, presumably, she was hoping for: a private jet.

"Do you have any idea" what that costs, Ms. Watson Coleman wanted to know. Ms. Bresch's voice caught when she answered. "Look," she said carefully, "I know that it's fortunate." She then said the company executives traveled this way for efficiency and safety reasons. They flew from Pittsburgh, she confirmed.

Louise Radnofsky

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"There is no transparency, that's the problem here!"

Georgia Republican Buddy Carter may not have heard his South Carolina GOP colleague Mick Mulvaney rail against ignorant questions earlier, but he's eager to show his stuff as a former pharmacist (the only one in the House or Senate, Mr. Chaffetz notes in introducing him.)

Mr. Carter has a mix of heavy questions, rhetorical and particular. Others had asked Ms. Bresch if she's seen a child experience a severe allergic reaction. Mr. Carter asked her if she has had to tell a mother the price of EpiPens was $600. "Have you ever seen a mother cry because she can't afford medication for her child?" he asks. "I have."

Then he asks her specific questions, about the flow of rebates between Mylan and pharmacy benefit managers, and when she can't answer, he builds to his broader conclusion. "There is no transparency, that's the problem here!" he cries.

The most immediate thing she could do, Ms. Bresch tries to say, is put a generic product into the market. "Do not do that to me," Mr. Carter says, who characterized the responses as a "a crock." "Do not try to convince me that you are doing me a favor here," he added.

"This is a shell game. That's all it is," Mr. Carter concludes.

Louise Radnofsky

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Legislators want to know why the EpiPen price is lower in the Netherlands

Vermont Democrat Peter Welch wants to know why if Ms. Bresch sells more EpiPens than she did before, the price isn't going down, rather than up. She explains there's "complexity" in the system. In response, Mr. Welch actually invites her to show her chart, and then wants to know why pharmacy benefit managers haven't negotiated lower prices with her. He also wants to know why prices are different for Mylan's products in the Netherlands, something chairman Jason Chaffetz is also interested in.

"What I would say is that they have a completely different system," she said.

Louise Radnofsky

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Blame It on the Regulatory Process

Republican Rep. Jody Hice of Georgia lambasted the FDA’s Mr. Throckmorton for what he considers an inefficient regulatory system for drug approval. As others have before him, he blamed that slow process for the lack of competition in the market and the subsequent price gouging.

“No wonder the whole system is not working,” said Mr. Rice.

He referenced the European regulatory process, which he suggested was better.

“The European system is quite different from others,” replied Mr. Throckmorton. “I would say they are apples and oranges.”

Daniela Hernandez

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Highlights

GOP Legislators Seem More Interested in Challenging the FDA

Republican Rep. Jody Hice of Georgia is focusing his ire on Mr. Throckmorton, keeping with the main partisan trend we have seen here today: GOP legislators are more interested in challenging the FDA; both sides have been eager to yell at Ms. Bresch.

Mr. Hice has probed the speed with which Mr. Throckmorton's agency approves applications and moves products through the pipeline. Mr. Throckmorton gets to speak, after a hearing in which he's either felt unable to answer questions or been ignored in favor of Ms. Bresch. There are about 2,300 applications before the agency, he says, and about 600 products have been moved through this year. "I don't think you'd want us to rubberstamp" others, he said.

Louise Radnofsky

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Could Mylan's rebate programs be considered kickbacks?

Democratic Rep. Mark DeSaulnier of California hasn't missed a beat, launching straight into a question about Mylan's lobbying. Ms. Bresch says that was primarily aimed at ensuring children could use treatment while they were in school. He asks about patient rebate programs characterized by some as "kickbacks" that don't address underlying costs. She responds by saying that these are all reasons why the company now offers a generic.

"How long did you have the profits under the old system before you switched to the generic?" asks Mr. DeSaulnier. "My point is you're making it sound like you introduced a generic purely for altruistic reasons."

Louise Radnofsky

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The Mylan Hearing Resumes

Mylan Inc. CEO Heather Bresch (R) listens to an aide during a hearing before the House Oversight and Government Reform Committee September 21, 2016 on Capitol Hill in Washington, DC. Alex Wong/Getty Images

Doug Throckmorton and Heather Bresch have both returned to the room, so let's assume that intermission is ending. Each has taken their seat at the witness table, but there are no more photographers staring them in the face. Also returning to the room, carried by men in suits sitting with other Mylan officials: those posters Ms. Bresch used a few hours ago.

Louise Radnofsky

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"You asked for it"

Mick Mulvaney was determined to make his points resonate even if he would be the last person heard by many of the folks tuning into this show. He accused his colleagues -- Republican and Democratic -- of showboating about matters they know nothing about, from profit margins to distribution systems to appropriate salaries for pharmaceutical executives and whether $18 million in compensation is even possible. "I'm not comfortable with that," he said.

But, he told Ms. Bresch -- over and over again -- "You asked for it" by lobbying for EpiPen acquisitions, or, as he put it, coming "in these hallways to ask us to make people buy your stuff." The result, he said, is that "you get a level of scrutiny .. that would ordinarily curl my hair.. but you asked for it."

Once he was done, and the recess began, Ms. Bresch left the room flanked by an entourage. She did not say anything as a television reporter yelled questions about why she hadn't apologized.

Louise Radnofsky

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Here's a significant scheduling update

The vote buzzer is going, and after South Carolina Republican Mick Mulvaney finishes talking about better competition in Europe, members are heading back to the House floor for at least an hour. The hearing won't reconvene until 6:30 pm at the earliest.

Louise Radnofsky

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On the Quick Turnaround Time for the Mylan Hearing

There were some in Washington who didn't think this hearing would happen, because the window was so narrow between the August eruption of the EpiPen controversy and the planned return of members of Congress to their districts and the campaign trail at the end of September.

Legislators' references to documents and statements they've gathered as part of their investigation have been notably brief and unpolished. One explanation for that may be that committee staff have had a very short period in which to review their material. Mylan executives met with committee staff last Monday, and the hearing was scheduled last Wednesday. That's not much of a turnaround time.

Louise Radnofsky

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Lots of Criticism, Little Talk of Solutions

Mylan, and to a lesser extent the Food and Drug Administration, has come in for lots of criticism during a hearing that has now surpassed two hours. But what hasn't received much attention is what, if anything, should be done to address hefty price increases for drugs.

This is the million-dollar question for patients, companies and Wall Street.

Politicians have called out examples of dramatic drug price increases and high drug costs, and floated a range of potential counter actions, such as permitting the importation of drugs from other countries. Several states are considering transparency measures.

What is unclear, and remains unclear from this hearing so far, is whether the rhetoric will actually result in real action and what that might be.

Jonathan D. Rockoff

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Questions Persist About Lobbying by Mylan CEO's Mother

In an impassioned monologue, Democratic Rep. Tammy Duckworth of Illinois accused Ms. Bresch of creating a monopoly for schools required to buy EpiPen. Ms. Bresch interjected to repeat denials about her mother's involvement in lobbying efforts being inappropriate. (This is an ongoing issue for Ms. Duckworth, who previously wrote to the U.S. Attorney General about the EpiPen4Schools program.)

Republican Rep. Blake Farenthold of Texas followed with a bizarre-sounding note of praise, telling Ms. Bresch he could see why she made $18 million after trying to figure out drug pricing himself.

He and Stacey Plaskett of the Virgin Islands, a Democrat, struggled to get traction with their questions. Ms. Plaskett focused on Mylan's efforts to provide their product to families of four with incomes lower than $97,000, but complained that was much higher than the average income in her district. As the Journal has explained, many consumers have struggled the most when they exceed eligibility for consumer assistance programs.

“That doesn’t even pass the giggle test"

The issue of competition--or lack thereof--continues to be a theme of this hearing.

Mylan is said to "control" more than 90% of the market, according to Congressman Gerry Connolly (D-Virginia).

Ms. Bresch acknowledged that Mylan was the biggest player in the market, but wouldn't concede it controls or has a stronghold.

“That doesn’t even pass the giggle test," Mr. Connolly retorted. "You virtually have a monopoly...Unfortunately it’s at the expense of people who need it,” he said, referring to the EpiPen.

Daniela Hernandez

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Tempers Are Getting Even Shorter

EpiPens that Mylan CEO Heather Bresch bought with her are seen on Capitol Hill in Washington, Wednesday, Sept. 21, 2016, as she testified before the House Oversight Committee hearing on EpiPen price increases.Pablo Martinez Monsivais/Associated Press

Main takeaways as this hearing enters its middle phase: tempers are getting even shorter. Democratic Rep. William Lacy Clay of Missouri railed against corporate America.

It's no different from Rep. Scott DesJarlais, a Tennessee Republican -- and he's hardly an ideological companion to those men. "So you decided you should raise the price?", "Do you think $600 is too much?", "Did you plan on increasing the price in 2017?" and "We're supposed to feel good?" were all questions he asked in a rapid-fire back-and-forth with Ms. Bresch.

She said she believed the previous price had been fair, that it needed to be lowered through a generic offering because "the system wasn't intended for people to pay the wholesale acquisition cost." She also said she was proud of the company's record of giving away hundreds of thousands of devices to schools.

"You're trying to make us feel good about that and we're not. I'm just not buying it," grumbled Mr. DesJarlais about her answers. "If it cost $20 they could afford to buy their own."

Louise Radnofsky

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Highlights

It's Time For the $64,000 Question

Rep. Tim Walberg (R., Michigan), filling in for Mr. Chaffetz in the chair, goes for what he thinks is the $64,000 question: won't Mylan's latest efforts to introduce its own generic "just shift the full cost of EpiPens to government" and other payers, like employers and private insurance companies?

Ms. Bresch offers an answer about ensuring minimal out-of-pocket costs for consumers and adds that "this is not all about cost-shifting. It's just making sure that everyone" can get the product. Mr. Walberg doesn't pursue it, observing instead only that "it certainly takes the pressure off bad publicity."